SupraSDRM®

FDA UDI

Class U (US FDA UDI)

by Polymedics Innovations, Inc.

Identity

Trade Name: SupraSDRM® FDA UDI
Generic Name: Synthetic wound matrix dressing FDA UDI
Device Name: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of superficial dermal wounds, split-skin graft donor sites, pressure and venous ulcers, and 2nd degree burns. The biodegradable matrix is designed for trauma and surgical wounds involving soft tissues. The SupraSDRM matrix is available in various sizes for use in covering and protecting superficial and partial thickness soft tissue wounds. FDA UDI
Model / Reference: SupraSDRM Disk18 FDA UDI
Description: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of superficial dermal wounds, split-skin graft donor sites, pressure and venous ulcers, and 2nd degree burns. The biodegradable matrix is designed for trauma and surgical wounds involving soft tissues. The SupraSDRM matrix is available in various sizes for use in covering and protecting superficial and partial thickness soft tissue wounds. FDA UDI

Identifiers

Catalog Number: 31D018-US FDA UDI
Primary DI / UDI-DI: 04260184023127 FDA UDI
510(k) Number: K170213 FDA UDI
FDA Product Code: QSZ FDA UDI
GMDN Term: Synthetic wound matrix dressing FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Synthetic wound matrix dressing

SupraSDRM® by Polymedics Innovations, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Synthetic wound matrix dressing.

SiOxD Wound Matrix — Sioxmed, LLC · U
NovoSorb MTX — Polynovo Biomaterials Pty, Ltd. · U
NovoSorb BTM — Polynovo Biomaterials Pty, Ltd. · U
MIRRASURG™ — ETS WOUND CARE LLC · U
MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC · U
MIRRAGEN® Advanced Wound Matrix — ETS WOUND CARE LLC · U
Restrata MiniMatrix — Acera Surgical Inc · U
Restrata Wound Matrix — Acera Surgical Inc · U

Cleared under the same submission

K170213 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Polymedics Innovations, Inc.

Sources (1)

FDA UDI 6beda076-51c8-4afd-89c0-7cdbb641dafe 37 fields · synced May 30, 2026